Kornimate/medical-research-clean huggingface dataset:
study of cm512 in healthy subjects and patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase i study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of cm512 in healthy subjects and patients with moderate to severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * have the ability to understand the study and voluntarily sign a written informed consent form (icf). * body mass index (bmi) ranges from 18.0 to 26.0 kg/m2 (including boundary values). exclusion criteria: * have participated in any clinical trials of drugs or medical devices within 3 months before the screening. * have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening. * have lost more than 400 ml of blood due to blood donation or other reasons within 3 months before screening. * positive drug abuse test or positive alcohol breath test result.
a pilot study for the treatment of patients with metastatic and high risk sarcomas and primitive neuroectodermal tumors

Conditions: Neuroectodermal Tumor, Primitive; Neuroepithelioma; Osteosarcoma; Sarcoma; Sarcoma, Ewing's

Summary: this protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide vp-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. this will not be a randomized study but will be comparable to the large data base of similar patients treated on successive pediatric branch studies.

this protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide vp-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. this will not be a randomized study but will be comparable to the large data base of similar patients treated on successive pediatric branch studies.

Eligibility criteria:
patients with high grade soft tissue sarcomas and either metastatic disease or stage iii tumors including synovial sarcoma, malignant fibrous histiocytoma, hemangiopericytoma, malignant schwannoma (neurofibrosarcoma). patients must not have been previously treated with chemotherapy or radiation therapy. the patients age must be less than or equal to 25 years. the patient (or their guardian if under 18 years of age) must sign a document indicating that he/she is aware of the investigational nature of this treatment protocol and the potential risks and benefits that may be expected. patients must have a direct bilirubin of less than 4.0 mg/dl. patients must not have abnormal cardiac function (ejection fraction greater than 45% on muga scan with confirmation of shortening-fraction greater than 25% on echocardiography).

Keywords: combined chemotherapy irradiation unresectable
oxaliplatin and capecitabine in the treatment of relapsed/refractory carcinoma of unknown primary site

Conditions: Neoplasms, Unknown Primary

Summary: in this phase ii trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.

all patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. capecitabine 1000mg/m2 po bid was administered on days 1-14 of each cycle.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * histologically confirmed carcinoma of unknown primary site * progressive disease after treatment with one previous chemotherapy regimen. * treatment with one previous immunotherapy or biotherapy regimen. * no previous treatment with oxaliplatin, capecitabine, or 5-fu. * previous treatment with other platinum agents * patients must have measurable or evaluable disease * ecog performance status more than 2 * adequate bone marrow, liver and kidney function * understand the nature of this study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * age \< 18 years * history of treatment of any invasive malignancy within the last 5 years * coexistent medical illnesses * clinically significant cardiac disease * preexisting peripheral neuropathy \> grade 1 * lack of physical integrity of the upper gastrointestinal tract * pre-existing uncontrolled coagulopathy * women who are pregnant or lactating please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: neoplasms, unknown primary
magnetic resonance (mr) imaging in the post operative follow-up of cholesteatoma in children

Conditions: Cholesteatoma

Summary: classical imaging techniques are inaccurate to detect residual cholesteatoma. the aim of our study is to evaluate the value of diffusion-weighted mr imaging and delayed contrast enhanced t1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

classical imaging techniques are inaccurate to detect residual cholesteatoma. thin-section ct detects that the postoperative cavity is filled with a soft tissue mass. classical mr imaging (t2 and t1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.

Eligibility criteria:
inclusion criteria: * female or male child enters 5 and 18 years * child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral * child for whom an additional operating time is indicated * child without contraindication in the mri * child having signed a enlightened assent * child among whom the parents or the legal representatives signed a enlightened assent exclusion criteria: * child of less than 5 years old and more than 18 years * child presenting a chronic renal insufficiency * child for whom an additional operating time is not indicated * child having a contraindication in the mri * child not having signed the assent or the parents of which did not sign the assent
the safety and efficacy of epidural oxycodone

Conditions: Pain, Postoperative

Summary: there are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. in a study by bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. in another study, yanagidate and dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. in our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone. in the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.


Eligibility criteria:
inclusion criteria: * planned gynecological lower abdomen surgery with epidural pain treatment * informed consent obtained exclusion criteria: * planned surgery under regional anesthesia * contraindication to the study drug * contraindication to the lumbar puncture * contraindication to oxycodone * pregnancy or lactation * no informed consent
study evaluating bosutinib-letrozole combination versus letrozole alone in post menopausal women with breast cancer

Conditions: Breast Cancer

Summary: this is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. this is a 2-part study. subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. the second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. subjects will be followed up for survival after study drug discontinuation.

this study was terminated on 19 april 2009 due to unfavorable risk benefit ratio of bosutinib in combination with letrozole including one confirmed hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Eligibility criteria:
inclusion criteria: * surgically sterile or post-menopausal women. * confirmed pathologic diagnosis of breast cancer. * locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy. * documented er+ and/or pgr+ and erbb2- tumor based on most recently analyzed biopsy, as documented by a local laboratory. * at least 1 radiologically measurable lesion as defined by response evaluation criteria in solid tumors (recist). * eastern cooperative oncology group (ecog) performance status 0-2. exclusion criteria: * prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior src inhibitor. * prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant aromatase inhibitor (ai) agent/regimen is permitted). * more than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer. * adjuvant endocrine therapy \<=12 months prior to day 1 of treatment. * disease refractory (ie, progressive disease (pd) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy. * bone or skin as the only site of disease. * extensive visceral disease or active central nervous system (cns) disease. * any other cancer within 5 years of screening with the exception of er+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin. * major surgery or radiotherapy within 14 days of treatment day. * inadequate hepatic/renal/bone marrow function. * history of clinically significant or uncontrolled cardiac disease. * serious concurrent illness.
randomized comparison of low and conventional irradiance pdt for skin cancer

Conditions: Non-melanoma Skin Cancer

Summary: this study aims to examine whether the pain of topical photodynamic therapy (pdt) is significantly different when using low irradiance ambulatory light emitting diode (led) devices compared with conventional higher irradiance hospital based led light sources when used for superficial non-melanoma skin cancer. the investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.

a randomized assessor-blinded comparative study of low irradiance ambulatory led devices with conventional hospital-based led devices for superficial non-melanoma skin cancer. preliminary observations suggest that low irradiance leds cause less pain but are as effective, so the investigators are examining this in a clinical trial of patients with lesions \</= 2cm diameter of non-melanoma skin cancer (bowen's disease and superficial basal cell carcinoma). patients with these conditions referred to the pdt clinic will be invited to participate and if they are eligible and consent to treatment then they will be prospectively randomized to either ambulatory pdt or conventional pdt. pain and phototoxicity scores will be recorded and clinical efficacy will be assessed up to one year after the last treatment. computer-generated block randomization will be performed and at 90% power to detect as significant at the 5% level a mean difference in pain score of 2 in one group compared with 4 in the other, 36 patients will be needed, and as the participants will often be elderly and frail the investigators will aim for a safety margin of recruiting 50 participants to account for drop-outs. participants will receive two treatments of either arm at a one week interval and will be assessed clinically at three months and if residual disease remains then the two treatments a week apart are repeated. pain assessed using a visual analogue scale (vas) score and phototoxicity on a semi-quantitative scale are recorded at 7 days when the participant returns for their second treatment. follow up for clinical assessment is at 6 months and one year after treatment. participants also give their opinion of treatment at one year follow up. assessors of adverse effects and efficacy will be blinded. data recording and analysis will be undertaken by the study statistician dr robert dawe and analysis will be on an intention to treat basis using appropriate statistical tests comparing the pre-planned outcome measures, with pain as primary outcome and outcome, efficacy and patient satisfaction as secondary outcomes

Eligibility criteria:
inclusion criteria: * bowen's disease or superficial basal cell carcinoma referred for pdt and lesion not greater than 2.4cm diameter exclusion criteria: * unable to give consent, \>2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere
an integrated radio-immunological approach

Conditions: Glioma, Malignant

Summary: the most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. during tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal mri imaging technique with immunophenotyping of the tumor microenvironment.


Eligibility criteria:
inclusion criteria: * all patients with histologic confirmation of malignant glioma * patients must be age \>= 18 years * patients must be able to obtain an mri scan with gadolinium contrast * patients must sign informed consent indicating that they are aware of the investigational nature of this study:
measuring surgical recovery after radical cystectomy

Conditions: Bladder Cancer

Summary: the intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at md anderson cancer center and the collaborating institutions. the goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (pro) and clinician-reported outcomes (cro) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.


Eligibility criteria:
inclusion criteria: 1. bladder cancer patients undergoing radical cystectomy at the md anderson cancer center and the collaborating centers. exclusion criteria: n/a

Keywords: bladder cancer registry post-surgical outcomes radical cystectomy md anderson symptom inventory mdasi
probiotic for pain osteoarthritis

Conditions: Osteoarthritis of Multiple Joints

Summary: many people with symptomatic osteoarthritis (oa) report chronic joint pain, especially if those patients are older than 50 years. in europe oa is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including oa. gut microbiota has been proven to be of crucial importance in maintaining human health. however, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as oa. we hypothesize that these patients with pain-oa will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.


Eligibility criteria:
inclusion criteria: * all subjects will have hip or knee oa according on radiographic findings (kellgren-lawrence scale ≥3) and who require and eligible for chronic, daily therapy with an nsaids to control oa sign and symptoms. a physiatrist (physician) will establish the diagnosis of pain-oa. exclusion criteria: * psychiatric or neurological disorders, celiac disease, lactose intolerance, or allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes, ulcerative colitis, etc.) or recent antibiotic treatment (i.e., \<3 months before the beginning of the study). * participants with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc. * participants require treatment with aspirin \> 325 mg /day. * participants who smoked more than 10 cigarettes per day were excluded. * participants will be excluded also if they score greater than 6 points on the beck depression inventory (bdi) or more than 30 points in the state trait anxiety inventory (stai), dementia and not italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing. * post-traumatic oa (e.g., fractures), congenital hip deformities, surgical interventions to the hip or knee, legg-calvé-perthes disease, or degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded

Keywords: osteoarthritis pain microbiota
a study to evaluate combining metformin with muraglitazar or pioglitazone in type 2 diabetics

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetics * hba1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study. * fasting c-peptide ≥1.0 ng/ml * bmi≤41 kg/m2 mean fasting serum trig. ≤600 g/dl exclusion criteria: * symptomatic type 2 diabetics with \> 10% weight loss 3 months prior to study * history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling * history of mi (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (tia), cerebrovascular attack, or cerebrovascular accident (cva) within 6 months, congestive heart failure (nyha class iii and iv, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (pvd), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
microbiota restoration therapy for recurrent clostridium difficile infection

Conditions: Enterocolitis Clostridium Difficile Recurrent

Summary: this is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. patients who have had at least two recurrences of c. difficile infection (cdi) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe cdi resulting in hospitalization may be eligible for the study. patients whose cdi returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with rbx2660 in the open-label portion of the study.

this is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. the primary assessments for this study are (i) efficacy of rbx2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. patients who have had at least two recurrences of c. difficile infection (cdi) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe cdi resulting in hospitalization may be eligible for the study. patients whose cdi returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with rbx2660 in the open-label portion of the study.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * medical record documentation of recurrent cdi either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe cdi resulting in hospitalization. * documented history that the subject's recurrent cdi is controlled while on antibiotics even if the subject is not currently on antibiotics. * a positive stool test for the presence of c. difficile within 60 days prior to enrollment. exclusion criteria: * a known history of continued c. difficile diarrhea while taking on a course of antibiotics prescribed for cdi treatment. * requires antibiotic therapy for a condition other than recurrent cdi. * previous fecal transplant prior to study enrollment. * history of inflammatory bowel disease (ibd), e.g., ulcerative colitis, crohn's disease, or microscopic colitis. * history of irritable bowel syndrome (ibs). * history of chronic diarrhea. * history of celiac disease. * colostomy. * planned surgery requiring perioperative antibiotics within 6 months of study enrollment. * life expectancy of \< 12 months. * compromised immune system.

Keywords: clostridium difficile c diff cdi cdad fecal transplant fecal microbiota transplant diarrhea fmt microbiota restoration therapy microbiota suspension fecal bacteriotherapy c diff diarrhea
non-invasive diagnosis of pulmonary hypertension by impedance cardiography

Conditions: Pulmonary Hypertension

Summary: the goal of the study is to prospectively evaluate impedance cardiography as a tool to detect pulmonary hypertension. according to our hypothesis impedance cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. the main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.


Eligibility criteria:
inclusion criteria: * written informed consent * patients with clinical indication for right heart catheterization exclusion criteria: * known pregnancy

Keywords: impedance cardiography